TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
3D DIAGNOSTIX INC.
	SUBSTANTIALLY EQUIVALENT	1
AMPOWER DENTAL LABORATORIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
BELPORT COMPANY, INC., GINGI-PAK
	SUBSTANTIALLY EQUIVALENT	1
BERNHARD FÖRSTER GMBH
	SUBSTANTIALLY EQUIVALENT	1
DENTONA AG
	SUBSTANTIALLY EQUIVALENT	1
DETAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
DMG DIGITAL ENTERPRISES SE
	SUBSTANTIALLY EQUIVALENT	1
ENVISIONTEC GMBH
	SUBSTANTIALLY EQUIVALENT	2
ERKODENT ERICH KOPP GMBH
	SUBSTANTIALLY EQUIVALENT	1
FORMLABS OHIO, INC.
	SUBSTANTIALLY EQUIVALENT	2
FREY ORAL TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	1
GRINDGUARD INC
	SUBSTANTIALLY EQUIVALENT	1
HKABLE 3D BIOLOGIC PRINTING TECHNOLOGY(CHONGQING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LIJIA LLC
	SUBSTANTIALLY EQUIVALENT	1
LUXCREO INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIS INVESTMENT GROUP
	SUBSTANTIALLY EQUIVALENT	1
MYCONE DENTAL SUPPLY CO. INC. (DBA KEYSTONE INDUSTRIES)
	SUBSTANTIALLY EQUIVALENT	1
MYOHEALTH TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
PANTHERA DENTAL INC.
	SUBSTANTIALLY EQUIVALENT	1
PRISMATIK DENTALCRAFT, INC.
	SUBSTANTIALLY EQUIVALENT	2
PRO3DURE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PRO3DURE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
SLOW WAVE INC.
	SUBSTANTIALLY EQUIVALENT	1
SPLINTEK, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPRINTRAY INC
	SUBSTANTIALLY EQUIVALENT	1
VERTEX-DENTAL BV
	SUBSTANTIALLY EQUIVALENT	1
VOCO GMBH
	SUBSTANTIALLY EQUIVALENT	1
WHIP MIX CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	262	262
Insufficient Information	191	191
Patient-Device Incompatibility	4	4
Patient Device Interaction Problem	3	3
Failure to Osseointegrate	1	1
Product Quality Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Appropriate Term/Code Not Available	1	1
Loss of Osseointegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	314	314
Swelling/ Edema	26	26
Reaction	21	21
Discomfort	18	18
Inflammation	14	14
Pain	14	14
Burning Sensation	12	12
Itching Sensation	11	11
Blister	10	10
Unspecified Infection	5	5
Swelling	5	5
Ulcer	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Rash	4	4
Numbness	4	4
Dyspnea	4	4
Insufficient Information	3	3
Pressure Sores	3	3
Sore Throat	3	3
Patient Problem/Medical Problem	2	2
Nausea	2	2
Local Reaction	2	2
Irritation	2	2
Erythema	2	2
Cough	2	2
Unspecified Tissue Injury	2	2
Joint Contracture	2	2
Hemorrhage/Bleeding	2	2
Failure of Implant	1	1
Skin Inflammation/ Irritation	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Muscular Rigidity	1	1
Encephalitis	1	1
Choking	1	1
Abscess	1	1
Neck Stiffness	1	1
Headache	1	1
Tinnitus	1	1
Deformity/ Disfigurement	1	1